Therapeutic Classification: allergy, cold and cough remedies (antitussive), opioid analgesics
Pharmacologic Classification: opioid agonists nonopioid analgesic combinations
High Alert
Absorption: Well absorbed following oral administration.
Distribution: Unknown.
Half-Life: 2.2 hr; Extended release: 8 hr.
Noted for hydrocodone only; see acetaminophen/ibuprofen monographs for specific information on individual components.
Contraindicated in:
Use Cautiously in:
Use during pregnancy only if potential maternal benefit justifies potential fetal risk. Chronic maternal treatment with opioids during pregnancy may result in neonatal opioid withdrawal syndrome
;Noted for hydrocodone only; see acetaminophen/ibuprofen monographs for specific information on individual components.
CV: hypotension, bradycardia, QT interval prolongation (Hysingla only)
Derm: sweating
EENT: blurred vision, diplopia, miosis
Endo: adrenal insufficiency
GI: constipation, dyspepsia, nausea, choking, dysphagia, esophageal obstruction, vomiting
Neuro: confusion, dizziness, sedation, euphoria, hallucinations, headache, unusual dreams
Resp: RESPIRATORY DEPRESSION (INCLUDING CENTRAL SLEEP APNEA AND SLEEP-RELATED HYPOXEMIA)
Misc: allodynia, opioid-induced hyperalgesia,
physical dependence
,psychological dependence
, toleranceDrug-drug:
CYP3A4 inhibitors, including ritonavir, ketoconazole, itraconazole, fluconazole, clarithromycin, erythromycin, nefazodone, diltiazem, verapamil, nelfinavir, and fosamprenavir, may ↑ levels and risk of opioid toxicity; careful monitoring during initiation, dose changes, or discontinuation of the inhibitor is recommended.
CYP3A4 inducers, including barbiturates, carbamazepine, efavirenz, corticosteroids, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, or rifampin, may ↓ levels and analgesia; if inducers are discontinued or dosage ↓, patients should be monitored for signs of opioid toxicity and necessary dose adjustments should be made.
Use with benzodiazepines or other CNS depressants, including other opioids, nonbenzodiazepine sedative/hypnotics, anxiolytics, general anesthetics, muscle relaxants, antipsychotics, and alcohol, may cause profound sedation, respiratory depression, coma, and death; reserve concurrent use for when alternative treatment options are inadequate.
Drug-Natural Products:
Renal Impairment
Hepatic Impairment
Hydrocodone
(Generic available)Hydrocodone/Acetaminophen
(Generic available)Hydrocodone/Ibuprofen
(Generic available)Assess BP, HR, and respiratory rate before and periodically during administration. If respiratory rate <10/min, assess level of sedation. Dose may need to be ↓ by 2550%. Respiratory depression does not ↑ in severity, only in duration, with ↑ dose. Monitor for respiratory depression, especially during initiation or following dose ↑; serious, life-threatening, or fatal respiratory depression may occur. May cause sleep-related breathing disorders (central sleep apnea, sleep-related hypoxemia).
Prolonged use may lead to physical and psychological dependence and tolerance. This should not prevent patient from receiving adequate analgesia. Patients who receive opioids for pain rarely develop psychological dependence. If progressively higher doses are required, consider conversion to a stronger opioid. Prolonged use of opioids should be reserved for patients whose pain remains severe enough to require them and alternative treatment options continue to be inadequate. Many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine.
Assess risk for opioid addiction, abuse, or misuse prior to administration. Abuse or misuse of extended-release preparations by crushing, chewing, snorting, or injecting dissolved product will result in uncontrolled delivery of hydrocodone and can result in overdose and death. Hysingla ER is an abuse deterrent formulation that is difficult to crush and, if crushed, results in a gel.
Lab Test Considerations:
Toxicity and Overdose:
Ensure accuracy when prescribing, dispensing, and administering hydrocodone bitartrate and acetaminophen oral solution. Dosing errors due to confusion between mg and mL can result in accidental overdose and death.
Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding. Inform patient of potential for neonatal opioid withdrawal syndrome with prolonged use during pregnancy. Monitor neonate for signs and symptoms of withdrawal symptoms (irritability, hyperactivity and abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, failure to gain weight); usually occur the first days after birth. Monitor infants exposed to hydrocodone through breast milk for excess sedation and respiratory depression. Chronic use may ↓ fertility in women and men.
HYDROcodone: Hysingla ER, Zohydro ER,
HYDROcodone/Acetaminophen: Anexsia, Norco, Vicodin,
HYDROcodone/Ibuprofen: Reprexain